Z-2124-2025Class II

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Name: Z-2124-2025 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Creator: Microbiologics Inc
Published: 2025-06-17
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-06-17 / Open, Classified

FDA source

Microbiologics Inc began a recall of KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L on 2025-06-17. FDA classified it as Class II and gives the reason as "Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2124-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-17
Posted: 2025-07-17
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
FDA root cause: Under Investigation by firm
Action: On June 17. 2025, the firm began notifying affected customers via "Urgent Medical Device Recall" letters delivered through email. Customers were instructed to review lab procedures to understand how the information may affect usage; use or discard product depending on lab procedures. Complete and return the response form to [email protected]. If product was further distributed or transferred to other facilities or customers, they should also be notified. Customers may contact Microbiologics if a replacement kit is needed. If you have any questions or concerns, contact Recall Support team at 320.229.7080 or [email protected]. Collect calls may be made.
Quantity in commerce: 21 total
Distribution: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Product codes and lots: Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2124-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)